Fluoxetine and suicide

Healy, David; Creaney, William J.

doi:10.1136/bmj.303.6809.1058-b

Cited by 6 publications

(1 citation statement)

References 12 publications

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“…[90] A meta-analysis of data from 17 double-blind clinical trials did not show any increased prevalence of suicidal acts or ideation with fluoxetine in comparison with placebo or tricyclic antidepressants. [ 91 1 However, Healy and Creaney [92] have criticised the use of item 3 of the HDRS in the meta-analysis as being too insensitive for a sole measure of suicidal ideation.…”

Section: Evidence Against An Association With Fluoxetinementioning

confidence: 99%

Fluoxetine

Harris¹,

Benfield²

1995

Drugs & Aging

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The selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitor fluoxetine is an effective antidepressant in elderly patients. Its efficacy is similar to that of other frequently used antidepressants, such as the tricyclic antidepressants. However, compared with the tricyclic antidepressants, fluoxetine has a more favourable tolerability profile and is less toxic in overdose. It is associated with fewer anticholinergic, cardiovascular and CNS adverse events, but greater numbers of gastrointestinal adverse events than have been reported for the tricyclic antidepressants. This is important in elderly patients who are more at risk of developing central anticholinergic and cardiovascular effects than are younger patients. Therefore, while its position relative to other selective serotonin reuptake inhibitors requires investigation, fluoxetine represents a major advance over tricyclic antidepressant agents in the treatment of elderly patients with depression, predominantly because of its favourable tolerability profile.

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Section: Evidence Against An Association With Fluoxetinementioning

confidence: 99%

Fluoxetine

Harris¹,

Benfield²

1995

Drugs & Aging

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Fluoxetine and suicide: Meta‐analysis and Monte‐Carlo simulations

Po¹

1993

Pharmacoepidemiology and Drug

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Objective: To test the validity of the conclusion of a recent meta‐analysis1 of the possible association between fluoxetine and suicidal acts. Design: Monte‐Carlo simulations of the number of suicidal acts in clinical trials of the sizes reported in the published meta‐analysis.1 Main outcome measures: Simulated incidence of suicidal acts using binomial distributions with parameters equal to or higher than those reported in earlier papers. A pooled risk difference and the associated 95% confidence interval were calculated for each set of simulated data. Results: Assuming a true incidence of 0.3% of suicidal acts in patients receiving fluoxetine and 0.2% in patients receiving placebo, none of 30 sets of simulations showed a significant difference as judged by the pooled risk differences and the corresponding 95% confidence intervals. Even when the risk of suicidal acts was increased to 0.6%, only 38 of 100 simulations produced significant differences in the expected direction. Of the other 62 sets, 56 produced a non‐significant positive risk difference and six produced a non‐significant negative risk difference. Conclusion: The Monte‐Carlo simulations show that the meta‐analysis which claimed to demonstrate that the available data do not show that fluoxetine is associated with an increased risk of suicidal acts, was of low power. Much larger studies are needed before one can say categorically that fluoxetine is not associated with a higher incidence of suicidal acts than placebo. Conversely, the data to date (as the recent meta‐analysis rightly claim) also fail to demonstrate that the risk of suicidal acts is higher with fluoxetine than with placebo.

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